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Within months, one of the three latest immuno-oncology drugs from Chinese firms Innovent, Junshi and Akeso is likely to be approved, providing new competition to global giants such as BMS and Merck & Co. as they race each other over to the finish line.
The Madrid-based group's Aplidin is set to go back yet again to European regulators but the sea squirt-derived drug seems to be showing more potential in COVID-19 than in multiple myeloma.
The number of novel products launched in their first markets in 2020 hit record heights in spite of – and in part buoyed by – the pandemic, with an exceptional year for infectious diseases therapeutics and vaccines.
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
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